Atlas FDA

SHAPEMATCH CUTTING GUIDE

FDA 510(k) clearance K122053 · decided 2012-10-24

Clearance details

K-number
K122053
Device name
SHAPEMATCH CUTTING GUIDE
Applicant
Stryker Corp.
Decision
Substantially Equivalent
Date received
2012-07-13
Decision date
2012-10-24
Days to decision
103 days
Clearance type
Traditional
Product code
MBH
Device class
2
Regulation number
888.3565
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Alameda, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be recall (Z-1052-2013)Stryker Howmedica Osteonics Corp.2013-04-12

PMA approvals by this applicant

RecordFirmDate
VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033)Stryker Corp.2017-03-02
VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032)Stryker Corp.2015-07-16
VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031)Stryker Corp.2015-04-14
VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030)Stryker Corp.2015-04-13
VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029)Stryker Corp.2014-12-12
VITAGEL RT3 DELIVERY SYSTEM (P050044/S028)Stryker Corp.2014-06-05
VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026)Stryker Corp.2014-02-11
RT3 SURGICAL HEMOSTAT (P050044/S027)Stryker Corp.2014-01-27